Suture with toggle and method of manufacture therefor

ABSTRACT

The self securing suture includes a suture having a stiff end segment at a terminal end and a toggle disposed on the terminal end such that the stiff end segment and toggle define an acute angle between 25 degrees and 65 degrees. The toggle may be a metal or a biocompatible plastic. In one embodiment, a portion of the stiffened end segment is swaged onto the toggle in a closed channel. The present invention also includes methods for producing suture toggles. One method includes creating a partial channel on a toggle, stiffening an end segment of a suture thread, positioning a portion of the stiffened end segment in the partial channel, and swaging the toggle channel closed. The toggle and swaged suture thread may be coated with a biocompatible polymer. An alternative method of manufacture includes utilizing a tubular toggle, passing the stiffened end segment through the tube and swaging the toggle tube closed. In yet another method of manufacture for producing a suture toggle, a mold is utilized to form the toggle and the stiffened, positioned suture thread end segment.

[0001] This is a continuation-in-part patent application based uponpatent application Ser. No. 09/661,024 filed Sep. 13, 2000, currentlypending, which is a continuation of patent application Ser. No.09/413,145 filed Oct. 6, 1999, which is a regular patent applicationbased upon provisional patent application Ser. No. 60/143,555 filed Jul.13, 1999.

BACKGROUND OF THE INVENTION

[0002] In order to pass a suture through a tubular organ or otherstructure in a body (a human body or an animal), it is necessary totraverse the bodily structure, tissue or organ completely and encirclethe area where the physician or medical practitioner wishes to place thesuture. This traverse and encircle method works well in situations whereeasy access is available to the structure, tissue or organ and the itemto be sutured is easily viewed by the physician. In limited accesssituations (for example, in laparoscopic surgery, cardiac surgery andvascular surgery), the traverse and encirclement by sutures is oftentimes difficult, dangerous and at other times impossible.

[0003] As a further example, an attempt to suture a blood vessel througha small puncture wound is almost impossible. The direct suture of thearterial puncture is not possible.

[0004] The increasing utilization of minimally invasive surgicaltechniques has created a need for improved methods, suture systems andsuture placement devices under adverse conditions of limited access andlimited visibility of the suture site.

[0005] U.S. Patent No. 5,860,990 to Nobles et al. discloses a suturingdevice which includes sutures attached to needle points. The needlepoints are press fit onto the ends of delivery arms. The delivery armsare made of memory-shape nitinol. When the memory shape metal is freedfrom the lumen of a needle, the needle points, at the terminal ends ofthe metal arms, flare out laterally beyond the lumen of the needle. Thearms are then pulled proximally, causing the needle points to penetratethe vessel wall from inside out. The needle points are then captured bysuture catches which are also laterally disposed outboard of thedelivery system. The catches pull the needle points and draw in thesutures.

[0006] U.S. Pat. No. 5,053,046 to Janese discloses a dural sealingneedle. The dural ceiling needle includes a gelatin sealing compoundthat swells and sits between an impact cone cavity and an impact coneprotrusion. Wings spread out based upon the swelling of the gelatin sealand assist in the retention of the suture seal.

[0007] U.S. Pat. No. 4,744,364 to Kensey discloses a flexibledisc-shaped body at the end of a suture thread which expands after beingpushed out from the lumen of a delivery needle. In the lumen, the bodyis contracted or compressed.

[0008] U.S. Pat. No. 4,741,330 to Hayhurst discloses an apparatus foranchoring cartilage. The anchor is deformed in the lumen of a deliverytube, is thereafter pushed from the tube and springs laterally outwardupon exiting the tube. One of the embodiments of the suture includes aflexible anchoring device which has a U-shape when loaded within thedelivery needle. Hayhurst also discloses that “one end of the suture 12may be securely attached to the anchoring device 10 during the moldingor forming of the anchoring device. Preferably, the free opposite end 13of the suture is hardened or stiffened as by impregnation with asuitable plastics material.” col. 5, lines 21-26.

[0009] U.S. Pat. No. 4,705,040 to Mueller et al. discloses a suture witha T-shaped bar attached to the end of the suture. The bar is a stiffstainless steel tubing with an internal diameter of 0.025 inch and witha central hole formed in its side. The suture filament is fit within thehole and the bar heated to melt the end of the suture with the resultthat the resinous filament melts and draws into the form of a largecentral ball. When cooled and set, the ball is substantially larger thanthe hole, thereby creating a firm root for the filament within the bar.

[0010] U.S. Pat. No. 4,669,473 to Richards, et al., discloses a surgicalfastener or suture with a t-bar formed out of a resilient polymerizedresin. Richards T-shaped suture head has at least one portion of the Twith a sharp point so that when the head portion is implanted in thebody tissue, the head portion will attach itself securely to the tissueand will remain there despite a pulling force on the filament. Thesuture head is integral with the filament and the fastener is formed sothat the head normally extends at a right angle to the adjoining lengthof filament.

[0011] U.S. Pat. No. 4,006,747 to Kronenthal, et al., discloses H-shapedfasteners constructed of a flexible and resilient biocompatiblematerial. Each fastener has a filament with a rod-shaped head attachedat either end. Kronenthal discloses an embodiment in which the heads aremolded from the same material as the connecting filament. Kronenthalalso discloses an alternative embodiment wherein stainless steel headsare each attached by swaging multifilament suture which enters thefastener head at the midpoint thereof with one end of the suturefilament contained within one-half section of each head.

OBJECTS OF THE INVENTION

[0012] It is an object of the present invention to provide a suturewhich can be self secured on a bodily structure, tissue or organ with atoggle at the terminal end of the suture.

[0013] It is another object of the present invention to provide agenerally T-shaped toggle which latches on an interior or inboardsurface of a bodily structure, tissue and organ thereby permitting thebalance of the suture to be drawn in and wherein the toggle grasps thebodily structure, tissue and organ.

[0014] It is a further object of the present invention to provide atoggle configured as a bar at the end of a suture.

[0015] It is another object of the present invention to provide a metalwire suture with a T-shaped toggle or a toggle wire element attached tothe terminal end of a suture wire.

[0016] It is a further object of the present invention to provide asuture thread and a toggle wherein the toggle includes a protruding legor tab which is utilized by a needle delivery system to insert thesuture toggle into the bodily structure, tissue or organ.

[0017] It is a further object of the present invention to provide aself-securing suture toggle wherein the suture thread and toggle areattached to form an acute angle.

[0018] It is a further object of the present invention to provide amethod of manufacture to produce self-securing suture toggles withtoggles attached at an acute angle to the suture thread.

[0019] It is a further object of the present invention to provide asuture toggle in which an end segment of the suture thread is stiffened.

[0020] It is a further object of the present invention to provide asuture delivery system including a slotted needle, within which isseated the leg or tab of the toggle, which assists in the process ofinserting the suture toggle into the bodily structure, tissue or organ.

[0021] It is another object of the present invention to provide a selfsecuring suture with a toggle which can be used for minimally invasivesurgical techniques.

[0022] It is a further object of the present invention to provide asuture delivery system and toggle sutures utilized in laparoscopicprocedures.

SUMMARY OF THE INVENTION

[0023] The self securing suture includes a suture having a stiff endsegment at a terminal end and a toggle disposed on the terminal end suchthat the stiff end segment and toggle define an acute angle between 25degrees and 65 degrees. The toggle may include a metal body toggle or abiocompatible plastic body toggle. An embodiment of the suture toggleincludes a biocompatible coating of the toggle and stiff end segment. Inone embodiment, a portion of the stiffened end segment is swaged ontothe toggle in a closed channel. In another embodiment, a portion of thestiffened end segment is swaged onto the toggle in a closed cutout. Thepresent invention also includes methods for producing suture toggles.One method includes creating a partial channel on a toggle, stiffeningan end segment of a suture thread, positioning a portion of thestiffened end segment in the partial channel, and swaging the togglechannel closed about the portion of the stiffened end segment lyingtherein. The method may include roughening the channel surface prior toswaging. The method may also include aligning the stiffened end segmentand toggle such that the two define an acute angle. In addition, themethod may also include the step of coating the toggle and stiffenedsuture thread with a biocompatible polymer after the swaging step. Analternative method of manufacture for producing the suture toggleincludes the steps of creating a longitudinal passage through a toggle,forming a lateral hole through the toggle and into the passage,stiffening an end segment of a suture thread, placing the suture threadin the passage and through the hole of the toggle such that a portion ofthe stiffened end segment lies in the passage and protrudes from thehole, swaging the toggle closed about the captured stiffened endsegment, and coating the toggle and the portion of the stiffened endsegment of the suture thread with a biocompatible material. In yetanother method of manufacture for producing a suture toggle, a mold isprovided defining a toggle-shaped cavity and a suture thread-shapedcavity communicating therewith. The mold may also include a protrudingmember-shaped cavity communicating with the toggle cavity. The methodincludes stiffening a suture thread end segment, positioning the suturethread end segment within the suture thread cavity of the mold, andmolding a toggle onto the positioned suture thread end segment at anacute angle utilizing the mold. This method may be utilized such thatthe positioning step occurs prior to the stiffening step, and thestiffening step occurs substantially concurrently with the molding step.The stiffening of the suture thread end segment may be accomplished bycold dipping same into a polymer or spraying the end segment with abiocompatible acrylic.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Further objects and advantages of the present invention can befound in the detailed description of the preferred embodiments whentaken in conjunction with the accompanying drawings in which:

[0025]FIGS. 1A and 1B diagrammatically illustrate a suture with atoggle;

[0026]FIGS. 2A and 2B diagrammatically illustrate a suture deliveryneedle with and without the suture toggle;

[0027]FIGS. 3A, 3B, 3C, 3D and 3E diagrammatically illustrate theinsertion and deployment of the suture toggle and, more particularly,FIG. 3E generally diagrammatically illustrates the size relationshipbetween the suture toggle and a typical large artery in a human body;

[0028]FIGS. 4A, 4B and 4C diagrammatically illustrate a suture deliverysystem needle, a suture toggle and a modified delivery system;

[0029] FIGS. 5A-5F diagrammatically illustrate various protruding legs,tabs and other elements protruding from the toggle which assist indeployment of the suture toggle in the bodily structure;

[0030]FIGS. 5G and 5H diagrammatically illustrate various suture toggleswith depending tabs;

[0031]FIG. 6 diagrammatically illustrates a suture having two terminalends and two toggles;

[0032]FIG. 7 diagrammatically illustrates a suture toggle with twotoggles at both terminal ends of a suture thread, deployed about anarterial puncture site;

[0033] FIGS. 8A-8C diagrammatically illustrate other suture toggles;

[0034] FIGS. 9A-9B diagrammatically illustrate a suture delivery systemwith and without a suture toggle;

[0035]FIGS. 10A and 10B diagrammatically illustrate the deployment ofthe suture toggle illustrated in FIG. 8A;

[0036]FIGS. 11A, 11B and 11C diagrammatically illustrate other types oftabs protruding from toggles;

[0037]FIG. 12 diagrammatically illustrates a suture toggle deployed in asuture delivery needle;

[0038]FIGS. 13A and 13B diagrammatically illustrate a toggle configuredas a cylinder with a protruding side leg;

[0039]FIG. 13C diagrammatically illustrates a suture toggle configuredwith an angled T-bar deployed in a needle;

[0040]FIGS. 14A and 14B diagrammatically illustrate one delivery systemfor the suture toggle utilized in conjunction with minimally invasivesurgery;

[0041]FIGS. 15A and 15B diagrammatically illustrate front and side viewsof the suture delivery needle;

[0042]FIGS. 16A, 16B and 16C diagrammatically illustrate variousconfigurations of the needle retention body or structure;

[0043]FIG. 16D is a cross-sectional view of the delivery system from theperspective of section line 16D′-16D″ in FIG. 14A;

[0044]FIG. 17 diagrammatically illustrates an arterial puncture site ina large artery in a human;

[0045]FIG. 18 diagrammatically illustrates another type of suturedelivery system;

[0046]FIG. 19 diagrammatically illustrates an exploded view of thesuture delivery system shown inFIG. 18;

[0047]FIGS. 20A, 20B, 20C and 20D diagrammatically illustrate crosssectional views of the delivery system shown in FIG. 19 from theperspective of the corresponding section lines in FIG. 19;

[0048] FIGS. 21A-21F diagrammatically illustrate various configurationsof wire sutures and wire toggle elements;

[0049] FIGS. 22A-22D diagrammatically illustrate needle delivery systemsfor the wire suture toggles;

[0050] FIGS. 23A-23C diagrammatically illustrate a laparoscopic devicefor the suture toggle delivery system and

[0051]FIG. 23D is a cross-sectional view of a suture wire capture system(similar capture systems may be used with suture threads on the deliverysystems in FIGS. 14A and 18);

[0052] FIGS. 24A-24C diagrammatically illustrate major operational stepsto deploy suture toggles during laparoscopic surgery with the deliverysystem shown in FIG. 23A;

[0053]FIGS. 25A, B, C and D diagrammatically illustrate a hooked wiresuture;

[0054]FIGS. 26A and 26B diagrammatically illustrate a suture toggle withits toggle and suture thread defining an acute angle therebetween;

[0055]FIG. 27A diagrammatically illustrates a suture toggle with itstoggle angularly mounted on its suture thread;

[0056]FIG. 27B diagrammatically illustrates a cross-sectional view ofthe suture toggle from the perspective of section line 27B′-27B″ in FIG.27A;

[0057] FIGS. 28A, 28B1, 28B2, 28C, 28D, 28E, 28F1, 28F2, 28G1 and 28G2diagrammatically illustrate the steps in one method of manufacturing asuture toggle;

[0058] FIGS. 29A, 29B1, 29B2, 29C, 29D1 and 29D2 diagrammaticallyillustrate the steps in an alternative method of manufacturing a suturetoggle;

[0059]FIGS. 30A, 30B and 30C diagrammatically illustrate the steps in afurther alternative method of manufacturing a suture toggle;

[0060]FIGS. 31A and 31B diagrammatically illustrate alternativeembodiments of a toggle for the suture toggle;

[0061]FIG. 32 diagrammatically illustrates an alternative method ofmanufacturing a suture toggle;

[0062]FIG. 33 diagrammatically illustrates a suture toggle with aneccentrically mounted toggle; and

[0063]FIG. 34 diagrammatically illustrates a suture toggle with aneccentrically mounted toggle, mounted within a delivery needle.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] The present invention relates to self securing sutures, that is,sutures having toggles at the suture's terminal end, and various suturedelivery systems.

[0065]FIGS. 1A, 1B, 2A and 2B diagrammatically illustrate sutures havingtoggles at the terminal end and a needle delivery system used inconjunction with the suture toggles. FIGS. 14A and 18 diagrammaticallyillustrate simple delivery systems for the suture toggles. FIGS. 21A, B,C, D, E and F show wire suture toggles and FIG. 23A shows a deliverysystem for laparoscopic surgery or other type of surgery wherein thesurgeon seeks to suture fascia.

General Principles

[0066] By utilizing the toggle principle, it is possible to enter thebodily structure, tissue or organ and fix one end of a suture to thestructure or tissue without encircling the area. If two separate togglesutures are fixated in this fashion, it becomes possible to tie thosesutures with ease without the need for blind encirclement of the area inquestion. The increasing utilization of minimally invasive surgicaltechniques and arterial puncture site repair has created a need forimproved methods of suture placement under adverse conditions ofvisibility and access.

[0067] The toggle principal lends itself well to the placement andfixation of sutures, ligaments, etc. In this approach, a suture or wireor other flexible attachment or closure device is passed through or intothe tissue in a closed state. The “closed state” refers to the suturetoggle deployed in the needle. Upon applying tension after the toggleleaves the needle tip, the toggle is positioned so that it cannotretrace the path through which it was applied or inserted by virtue ofthe fact that its shape and position will no longer allow egress fromthe bodily structure or tissue. Structures such as sutures or ligamentsattached to the toggle are thereby fixed. One general embodiment of thisinvention consists of a T-shaped attachment to the end of a suture ofeither the same or different biocompatible material. The T bar isstiffer than the suture line, thread or wire and offers significantresistance to extraction from the bodily structure once deployed. Thesuture toggle design in fine wire allows the insertion of the toggle,but restricts the egress from the tubular structure. With respect towire sutures, provision is made for the applying or delivery device tosecure both wires together and close the defect by shortening the wireby the simple, but effective, expedient means of twisting the instrumentand its contained wires to secure them together. Provision is made toscore the wires at the appropriate location so that the wires divide orseparate upon twisting with a small, but secure, stub of twisted wire.In the alternative, a twisting and cutting instrument can be slid downthe two opposing wires after the applicator is removed and the wiresretained. This instrument would permit twisting and subsequent cuttingof the wires in a blind procedure.

Basic Details of Operation

[0068] The applying device or delivery system consists of a small hollowcore needle which allows it to be passed over a guide wire which hasbeen retained at the puncture site. The delivery system contains twosmall hollow needles in opposition at just the right distance on eitherside of the guide wire and, thus, the puncture site. In anotheriteration, the needle can be solid with hollow small toggle suture endsfitted over the needle rather than through them. In the first design,the needles are designed to contain the toggles and the wire or sutures.When the instrument is slid over the guide wire and through the skinincision site of puncture it is advanced until it is against the vesselor structure sought to be closed by a suture. In the case of a vein orartery, a “flashback” tube can be utilized in advance of the needles todemonstrate that the instrument is in the proper position. In addition,the length and design of the “flashback tube” is such that it protectsthe far wall of the structure, preventing toggling of two wallssimultaneously. The restricted length of the hollow needles alsoprotects opposite walls of the artery or vein. A slide moves the twoneedles distally and then advances the needles through the vessel orstructure wall until the toggles are deposited in the blood vessel withtheir trailing suture or wire leading from the vessel. The hollow needlealso acts as a flashback tube bilaterally. The shape of the toggle, asdesigned, prevents egress from the vessel and traction on the wire orsuture “sets” the T of the toggle flush against or in the structurewall. The suture is then tied or the wire twisted as appropriate.

[0069] Different toggle designs are provided as shown in theaccompanying drawings. In this fashion, puncture wounds or other defectsmay be easily closed utilizing simple and inexpensive devices. The costof complicated closure devices has been a deterrent to the universalacceptance of these previous devices. The utilization of a simple,inexpensive disposable device should remove many of the impediments foruniversal usage. The concept of toggling sutures for closure is new,safe and simple to use.

[0070] In one of the embodiments presented here, fine, partiallyannealed wire sutures are utilized to simplify the process by permittingfastening by simple twisting of the wires by the instrument, instead ofhaving to resort to complex methods of tying. Scoring the wires at theappropriate distance allows them to break with twisting at apredetermined location leaving only a small wire stump on top of thestructure.

[0071] Any biocompatible material for the suture toggle may be used suchas stainless steel wire, nylon sutures, or other synthetic biocompatiblematerial. The methods of tying the sutures may vary with the materialsused, but the toggling principle remains the same.

[0072]FIGS. 1A and 1B diagrammatically illustrate a suture 10 having asuture thread or suture body 12, a terminal end 13 and a toggle 14. FIG.1B shows a side view of suture toggle system 10. In the illustratedembodiment, toggle 14 is generally a solid rectangular shape having alength 1, a width w (FIG. 1B) and a depth d. The width w of the toggle14 is substantially similar to the outside diameter of the suture thread12 as shown in FIG. 1B. Toggle 14 has chamfered ends and edges, one ofwhich is chamfer edge 15. This chamfer reduces sharp edges. Further,toggle 14 includes an extending leg 16 protruding outboard away fromterminal end 13 of suture 12. Extending leg 16 defines, in combinationwith toggle body element 18, an open catch mouth 20 leading to anarrower throat 21. Mouth 20 has a gap size large enough to be capturedby a slot in the delivery needle discussed later. Leg 16 protrudes in adirection opposite the attachment of suture 12 to toggle 14.

[0073]FIGS. 2A and 2B diagrammatically show a suture delivery system 8which includes needle 24 having a lumen 26, a piercing terminal end 28and an open ended slot 30. Open ended slot 30, sometimes called a needletoggle slot herein, is open at the piercing end segment 28 of needle 24.

[0074] In the illustrated embodiment, piercing terminal end segment 28(typically a sharp edge) of needle 24 is angularly disposed with respectto the axial center line of needle 24.

[0075] Suture toggle system 10 is shown as disposed in lumen 26 ofneedle 24 in FIG. 2B. Toggle 14, and particularly protruding leg 16, isadapted to seat within slot 30 of needle 24.

[0076] FIGS. 3A-3D diagrammatically illustrate basic operationalcharacteristics of suture toggle system 10. Similar numerals designatesimilar items throughout all the drawings. In FIG. 3A, suture deliverysystem 8, consisting of needle 24 loaded with suture 12 and toggle 14,approaches a bodily structure, tissue or organ wall 31. As an examplethroughout the drawings (excepting drawings FIG. 24A-24C), referencewill be made to arterial wall 31. However, any type of bodily structure,tissue or organ may be sutured using the suture toggle system 10discussed herein. Wall 31 is representative of other bodily structurestissues and organs. Delivery system 8 approaches arterial wall 31 asshown by arrow 33. Piercing end 28 of needle 24 ultimately pierces andenters arterial wall 31.

[0077]FIG. 3B diagrammatically shows that needle 24 has fully enteredand passed through arterial wall 31. At this point in time, blood flowis noted by a “flash” from the lumen 26 of needle 24. Other “flash back”systems may be utilized. See central tube 62 in FIG. 14A. This flash ofblood provides a visual indication to the physician that the needle 24has fully penetrated into the lumen of the artery or other structure.

[0078] In FIG. 3C, the physician is withdrawing needle 24 and protrudingleg 16 of toggle 14 is caught on the inboard surface of arterial wall31. In FIG. 3D, needle 24 is withdrawn from arterial wall 31 and toggle14 and suture 12 is self secured in artery wall 31.

[0079]FIG. 3E diagrammatically illustrates the general proportional sizerelationship between artery wall 31, the artery in general, toggle 14and suture 12. To further illustrate one proposed embodiment of thesuture toggle, the following Exemplary Dimensional Table is provided.Exemplary Dimensional Table toggle head length 0.10-0.12 mm toggle headdepth 0.020 mm OD suture 3/0 nylon suture length 18 inches toggle headwidth 0.10-0.012 mm gap 0.008 mm or more typical delivery needle 0.028mm OD 0.023 mm ID 21 gauge large artery size about 7 mm ID

[0080]FIG. 4A diagrammatically illustrates toggle 14 and suture thread12 disposed in needle 24. Protruding leg 16 is also disposed in slot 30.However, suture thread 12A is disposed outside of needle lumen 26. Thisis accomplished by providing a secondary slot 34 within which passessuture thread A. Secondary slot 34 is sometimes referred to herein as asuture slot in the needle.

[0081]FIG. 4B diagrammatically shows open ended suture slot 34 atterminal end 29 of needle 24. Terminal end 29 of needle 24 is part ofpiercing terminal end 28. In the illustrated embodiment, suture slot 34is opposite toggle slot 30 which retains, in a loaded mode, protrudingleg 16 of toggle 14. The position of the suture slot relative to thetoggle slot varies dependent upon the position of the protruding leg,tab, wire element or loop on the suture toggle.

[0082]FIG. 4C diagrammatically shows needle 24 within which is loadedtoggle 14. Protruding leg 16 protrudes towards suture thread 12A. Inthis illustrated embodiment, slot 30 also operates as a suture slot. Inaddition, needle 24 includes rib 36 which enables the suture needle tobe inserted into the blood vessel 31 by a pushing in action.

[0083]FIGS. 5A through 5H diagrammatically illustrate variousmodifications of toggle 14. FIG. 5A diagrammatically illustrates toggle14 having a protruding leg 16 which protrudes outboard from the toggleopposite suture thread 12. Particularly, toggle 14 is a toggle bar. Asused herein, the term “toggle” refers to apiece or a device for holdingor securing suture thread 12. The term “toggle” also encompasses theconcept that it is a cross piece attached to the end of suture thread 12in order to prevent slipping or removal of the suture. The following BarShape Table provides some illustrative examples of the geometric shapeof the toggle bar. Bar Shape Table a straight piece of suture materialwhich is longer than it is wide rectangular oblong elliptical anelongated cylinder

[0084] As used herein, the term “bar” refers to a straight piece whichis longer than it is wide. As shown in FIG. 5A, leg 16 is formed from apartially separated segment of toggle bar 14. Remaining segment 18continues to form part of the toggle bar basic shape.

[0085]FIG. 5B shows a depending protruding leg 38 which protrudesinboard toward suture thread 12. Leg 38 is cut away or formed fromtoggle bar segment 39. Leg 38 is retained by and captured within openended toggle slot 30 of needle 24. Gap 20 between leg 38 and toggleremainder section 39 is one of the important features.

[0086]FIG. 5C diagrammatically illustrates toggle 14 including a tab 40depending from inboard surface 41 of toggle 14. Inboard surface 41 isintegral with or attached to suture terminal end 13. Surface 41 isinboard with respect to suture thread 12.

[0087]FIG. 5D diagrammatically shows tab 40 depending toward suturethread 12. FIG. 5D shows tab 40 consisting of either a solid triangularbody, a finger or a conical body. The width of tab 40 is smaller thantoggle 14. Protruding tab 40 has a raised terminal edge 42, see FIG. 5E,which faces away from suture thread 12. Tab 40 coacts with open endedslot 30 of suture delivery needle 24 (see for example FIG. 4B). The tabfits in toggle slot 30. In a different embodiment, suture slot may beplaced 90 degrees from toggle slot 30 (see FIG. 9C) to provide clearanceof the tab from the thread during withdrawal of needle 24.

[0088]FIG. 5F diagrammatically illustrates toggle 14 carrying two tabs40, 43 depending from inboard surface 41 of suture tab 14.

[0089]FIG. 5G diagrammatically shows tab 40 as a solid triangular body.Toggle 14 is also a solid rectangular body without chamfered edges.

[0090]FIG. 5H diagrammatically illustrates toggle 14 from theperspective of section line 5H′-5H″ in FIG. 5G. Tab 40 has a raisedterminal edge 42 which faces towards suture thread 14.

[0091] Accordingly, the tab can either face away from suture thread 12as in FIG. 5E or towards suture thread 12 as in FIG. 5H.

[0092]FIG. 6 diagrammatically shows toggles 14 and 14 a disposed atopposite terminal ends of suture thread 12. Suture thread 12 has alength Is which is, in one embodiment, about 16-18 inches.

[0093]FIG. 6 also shows that toggle 14 has been deployed beneath bodylayer 31.

[0094]FIG. 7 diagrammatically shows deployed toggles 14 and 14 a onblood vessel wall 31. The toggles are deployed beneath arterial wall 31.Arterial wall 31 is illustrated as having arterial puncture site 44.Toggles tabs 14, 14 a are deployed on either side of puncture side 44.Suture thread 12 connects toggles 14, 14 a. In operation, the surgeon orphysician ties off suture thread 12 thereby closing arterial puncturesite 44.

[0095]FIGS. 8A, 8B and 8C diagrammatically illustrate toggle 14 with aprotruding leg 16 along one side. Particularly, FIG. 8A diagrammaticallyshows toggle 14 as a toggle bar with chamfers along its side edges. Oneof the chamfers is identified as chamfer 15. A protruding leg 16 isformed by partly separating toggle 14 from remaining toggle segment 18.This creates an open mouth 20 which is disposed in the toggle slot inneedle 30. See FIG. 2A.

[0096]FIG. 8B shows a top view of toggle 14 and clearly shows thatprotruding and extending leg 16 is formed by partially separating leg 16from the remaining toggle body portion 18. The generally solid bodyrectangular toggle bar 14 has sides 2, 3, 4 and 5 which are generally inparallel planes with respect to the axial centerline of suture thread 12if the thread were laid out straight. Items protruding from toggle barwalls 2, 3, 4, 5 are normal (perpendicular) to the suture thread.

[0097]FIG. 8C shows a toggle end view and toggle mouth 20.

[0098] FIGS. 9A-9D show needle 24 with and without a retained togglesuture. FIG. 9A shows toggle slot 30 in needle 24 located approximatelymidway along piercing terminal edge 28 of needle 24. The toggle slot canbe re-positioned dependent upon the size of the suture, the leg or tab,and the item to be sutured. FIG. 9B also shows toggle slot 30 of needle24 approximately midway along needle piercing edge 28. FIG. 9B alsoshows toggle 14 deployed in toggle slot 30. Suture thread 12 runs orpasses through the lumen 26 of needle 24.

[0099] In FIG. 9B, slot 30 retains protruding leg 16 which protrudesfrom side edge 5 of the toggle bar. The side edge protruding leg 16 isshown in FIGS. 8A-8C. Leg 16 protrudes normal or perpendicular to suturethread 12.

[0100]FIG. 9C shows needle 24 having toggle slot 30 and suture threadslot 34. Suture thread slot 34 is formed or created approximately 90degrees from toggle slot 30.

[0101]FIG. 9D shows toggle 14 with a side end protruding leg 16 whereinsuture thread 12 runs through suture slot 34 of needle 24.

[0102]FIG. 10A shows toggle 14 deployed in arterial wall 31.

[0103]FIG. 10B is a detailed view showing toggle 14 deployed on aninboard surface of arterial wall 31. Currently, it is believed that thetoggle bar with a leg or tab protruding from bar side 2, 3, 4 and 5 ispreferable.

[0104]FIG. 8B shows toggle bar 14 with side surfaces 2, 3, 4 and 5. Itis currently believed that a tab or leg protruding from one of the sidesurfaces is better suited than an outboard extending tab or leg (seeFIG. 5A) or a depending tab or leg (see FIG. 5B). The depending leg orthe depending tab may injure an arterial 31 in certain situations. Whentoggle anchoring is required, the depending leg or wire is preferred. Anupstanding or outboard tab or leg may impede blood flow. However, insome applications, these tab-leg configurations may be beneficial ifthey achieve better attachment by the suture toggle on the bodystructure, tissue or organ. A side leg or tab is currently thought to bebetter than an outboard leg or tab (see outboard leg 16 in FIG. 1A)because an outboard protruding leg or tab may further complicate andimpede blood flow or fluid flow through the bodily structure, tissue ororgan, particularly if the structure is an artery or a vein.

[0105]FIG. 11 A diagrammatically shows toggle 14 having a protruding tab40 protruding from side surface 5 of the toggle bar.

[0106]FIG. 11B shows protruding legs or arms 50, 51 protruding from sidesurface 5 of toggle bar 14. A plurality of legs or tabs may be utilized.FIG. 11C shows toggle 14 with a generally planar triangular tab 40protruding from side face 5. Tab 40 in FIG. 11A is generally conical instructure with squared off surfaces. Tab 40 in FIG. 11C is generally aplanar triangle.

[0107]FIG. 12 shows toggle 14 with a triangular tab deployed within thelumen of delivery needle 24. Tab 40 of toggle 14 protrudes from toggleslot 30. Suture 12 is deployed such that it exits lumen 26 of needle 24near proximal edge region 52 of piercing terminal edge 28 of needle 24.Proximal region 52 may be rounded or smoothed to avoid cutting suturethread 12.

[0108]FIG. 13A and 13B diagrammatically illustrate toggle 14 configuredas a cylindrical bar with a laterally protruding leg 16. Leg 16 is alsocylindrically shaped and protrudes laterally from toggle bar element 18.Leg 16 is generally normal to suture thread 12. Leg 16 is not cut fromor separated from the cylindrical toggle bar.

[0109]FIG. 13C diagrammatically illustrates toggle bar 14 at an angle 9with respect to the axial centerline of suture thread 12. In thisconfiguration, the acute angle 7 between angled toggle bar 14 and suturethread 12 is disposed within suture slot 30 of needle 24. This angulatedconfiguration may enable long T-shaped bar deployment in needle 24. Theterm “long T-shaped” refers to the length of sides 3,5 (see FIG. 8B)relative to the cross-sectional dimension of suture thread 12. Thisimplementation may also avoid the use of protruding legs, tabs ormembers.

[0110] FIGS. 14-20 diagrammatically illustrate various suture deliverysystems.

[0111]FIG. 14A diagrammatically shows suture delivery system 60 whichincludes a basic or central tube 62 which runs over a guide wire 64.Guide wire 64 typically is not part of the suture delivery system. Theillustrated delivery system in FIG. 14A is used to close puncture woundsmade during catheterization. Guide wires 64 are used during such medicalprocedures. For purposes of explanation, suture delivery needles 66, 68carry suture toggles and suture threads generally shown and discussedearlier in connection with FIGS. 1-13.

[0112]FIG. 15A shows suture needle 66 having a piercing edge 67 and atoggle slot 69. FIG. 15B diagrammatically illustrates a side view ofsuture needle 66.

[0113] Returning to FIG. 14A, base tube 62 rides over guide wire 64 inorder to properly place suture needles 66, 68 on either side of arterialpuncture 44 shown in FIG. 7. Suture needles 66, 68 have piercing ends67, 67 a which are laterally deployed a distance 69 from base centraltube 62. In this suture delivery system, suture needles 66, 68 are madeof metal having a shape memory such that when needle end segment 70 isfree from needle containment or retaining structure 72, the distal endsof needles 66, 68 spring laterally outward a distance 69.

[0114] Needles 66, 68 run and protrude through needle retainer body 72and also protrude proximally from proximal end 74 of retainer 72 towardsthumb nut set 76. Proximal needle ends 75, 77 for needles 66, 68 aregenerally near thumb nut set 78.

[0115] Needle retention structure 72 has a proximal tube member 80 suchthat tube 80 runs over central tube 62. The operator moves needleretainer structure 72 by moving thumb nut set 78 in the direction shownby arrow 82. As shown in FIG. 16D, proximal tube 80 (attached to needleretainer body 72) has longitudinal slots 73 a, 73 b. Needles 66, 68 areattached to base or center tube 62. Hence, when tube 62 is stationaryand needle retainer 72 is moved, needles 66, 68 are either exposed (FIG.14A) or fully retained and covered (FIG. 14B).

[0116]FIG. 14B shows that needle retaining structure 72 has been pushedforward such that proximal ends 75, 77 of needles 66, 68 are proximateor near thumb nut set 78. Piercing edges 67, 67 a are disposed at, nearor below distal edges 79, 81 of needle retention structure 72. When thestructure delivery system 60 is placed on guide wire 64 and placed neararterial puncture site 44 (FIG. 17), thumb nut set 78 (mounted on tab 80and retainer 72) is then withdrawn in a direction opposite arrow 82 inFIG. 14A, and distal end 70 of needles 66, 68 are then exposed andsprung laterally outward due to the memory shape of the needles. Thesurgeon then places the distal end of tube 62 into arterial puncture 44(FIG. 17) and continues to move delivery system 60 down guide wire 64until he or she sees a flash of blood when piercing ends 67, 67 a ofneedles 66, 68 pierce arterial wall 31. A flashback may also occurthrough base tube 62. Toggle insertion generally occurs at sites 83, 85(FIG. 17). The surgeon then withdraws the needles thereby leaving thetoggle ends of the sutures on the inside arterial wall 31. The surgeoncan then close the arterial puncture after removal of guide wire 64 in amanner described above in connection with FIG. 7.

[0117]FIGS. 16A, 16B and 16C show different structures for needleretention structure 72. In FIG. 16A, retention structure 72 is generallycircular in configuration. The structure contains left and rightpassages 82, 84 within which pass needles 66, 68. A central passage 86permits passage of base tube 62.

[0118] In FIG. 16B, needle retention structure 72 is elliptical oroblong. In FIG. 16C, needle retention structure 72 includes a centralcylindrical body 88 and two side bodies 90, 92. Side body 90 has a lumenthrough which passes needle 66. Side body 92 includes a lumen throughwhich passes needle 68. Central body 88 includes a lumen through passescentral or base tube 62.

[0119]FIG. 17 shows that a typical size of the large artery havingdimension da which is approximately 7 mm (inside diameter) and puncturesite 44 has an approximate opening size ap of approximately 2-3 mm. Thelateral distance between respective piercing edges 37, 37 a of needles66, 68 is approximately 5-6 mm. The lumen of the suture toggle deliveryneedles 66, 68 is approximately 0.02 mm. Accordingly, the puncture forthe suture toggles is small compared with the size of the arterialpuncture which in turn is smaller than the inside diameter da of largeartery 31.

[0120]FIG. 18 diagrammatically shows delivery system 60 including ashaped element 94 which forces needles 66, 68 to move laterally in thedirection of arrows 96 a and 96 b outboard and away from central tube62. Shape element 94 acts as a cam surface and needles 66,68 follow theproximal cam surface of the shape 94. The proximal end segments ofneedles 66,68 are attached to outer tube 80 which is further attached toscrew set 78. When outer tube 80 moves forward and aft over central tube62, the distal ends of needles 66, 68 move forward and aft over camshape surface 94. Cam shape element 94 is mounted on central base tube62. The following Needle Delivery Flare Table describes some shapes ofthe cam shape 94. Needle Delivery Flare Table ball olive oblongfrustoconical angled ribs (with apex at a proximal end)

[0121]FIG. 19 diagrammatically shows an exploded view of delivery system60. Thumb screw set 78 is attached to the proximal end of needlecarrying tube 80. Needles 68, 68 are attached to carrying tube 80.

[0122]FIG. 20A shows needles 66, 68 from the perspective of section line20A′-20A″ in FIG. 19. The attachment of needles 66, 68 to needlecarrying tube 80 is shown in a cross-sectional view in FIG. 20B from theperspective of section line 20B′-20B″ in FIG. 19. The lumen 80 a ofneedle carrying tube 80 is large enough to accommodate central tube 62.Central tube 62 extends through needle carrier tube 80.

[0123] Needles 66., 68 and needle carrying tube 80 are placed overcentral or base tube 62. Guide wire 64 extends through lumen 63 ofcentral tube 62 when the system is deployed and in use.

[0124]FIG. 20C shows a cross-sectional view of central tube 62 from theperspective of section line 20C′-20C″ in FIG. 19. Needle retention body72 is mounted on central tube 62.

[0125] Needle retention body or structure 72 is mounted on central tube62. A cross-sectional view of one embodiment of needle retention body 72is shown in FIG. 20D. FIG. 20D is a view from section lines 20D′-20D″ inFIG. 19. Needle cam shape 94 is attached to the distal end of centraltube 62 slightly beyond needle exit ports 98, 99 of needle retentionbody 72. It should be noted that needle retention body 72 may take oneor more of the shapes illustrated above in connection with FIGS. 16A,16B and 16C.

[0126] To construct the delivery system shown in FIG. 19, needlecarrying tube 80 and needles 66, 68 are placed over central tube 62.Needles 66,68 are fed into needle entrance ports 97 a, 97 b. Needles 66,68 are placed into the left and right side needle lumens of needleretention structure 72 until they are proximate needle exit ports 98,99. Thereafter, thumb nut set 76 is placed on the proximal end ofcentral tube 62 by an appropriate attachment means (e.g., a thread).Accordingly, face 101 of set 76, along section lines 102′-102,″ is nearor adjacent face 103 of set 78 at section lines 104′-104″ which is theproximal end of thumb nut set 78. In a preferred embodiment, thumb nutset 78 may cooperate with thumb nut set 76 to lock the needle deliverysystem and suture delivery system together prior to deploying the systemon guide wire 64. After deployment, the system takes the configurationshown above in connection with FIG. 14B except central tube 62 includesa needle cam shape 94. This cam shape is absent from FIG. 14B.

[0127] At the time of suture toggle deployment, needle carrying tube 80is moved distally while central tube 62 remains stationary therebycausing needles 66,68 to leave exit ports 98,99 and move over needle camsurface shape 94. At that time, the distal ends of needles 66, 68 movelaterally outboard (relative to the axial center line) in the directionshown by arrows 96 a, 96 b in FIG. 18 until the piercing surfaces ofneedles 66, 68 are distally beyond the needle cam shape 94. At thattime, the operator inserts the distal end of central tube 62 intoarterial puncture 44 shown in FIG. 17. Thereafter, needles 66, 68 piercearterial wall 31, deposit the toggles in the artery's lumen and at theunderside of arterial wall 31 and the operator withdraws the needles bymoving thumb nut set 68 proximally with respect to central tube 62 whichis preferably held stationary. This causes needles 66, 68 to withdrawand laterally collapse since cam surface shape 94 no longer forces thedistal end of the needles to protrude laterally outward beyond centraltube 62. The needles are also drawn into needle retention body 72. Whenthe needles' terminal ends are at or near exit ports 98, 99, the entiredelivery system is withdrawn and the surgeon or physician ties off thesuture wire as shown in FIG. 7.

[0128] FIGS. 21-22 diagrammatically illustrate a toggle suture made ofwire. This wire may be stainless steel wire. The toggle may also bememory shape metal. In contrast, the sutures discussed above inconnection with FIGS. 1-13 are made of nylon or other syntheticbiocompatible material.

[0129]FIG. 21A shows suture wire 110 having a wire element toggle 114 atsuture terminal end 113. The wire is typically stainless steel but maybe an other type of biocompatible metal material. Wire element toggle114 includes a double strand segment 116. Wire element toggle 114 isangularly disposed, that is, disposed over angle 118 a with respect tothe axial central line of suture wire 110. In addition, wire elementtoggle 114 includes a depending wire tip section 118.

[0130]FIG. 21B shows wire element toggle 114 disposed on an inboard sideof body structure, tissue or organ layer 31. Depending wire element 118protrudes into body layer 31 thereby locking or anchoring the togglesuture in place.

[0131]FIG. 21C shows wire suture 110 with a wire element toggle 114being normal with respect to the suture wire. The angular disposition oftoggle 114 to the axial centerline of laid-out suture wire 110 isrelated to the needle delivery system and the spring action and toggleor latch action of the suture toggle.

[0132]FIG. 21D shows that depending leg 118 is angularly disposed atangle 121 with respect to the central axis of wire element toggle 114.The angular position is related to the needle delivery system and thedegree of locking necessary on bodily structure 31.

[0133]FIG. 21E shows suture wire 110 having a wire body 122 (about16″-18″) and having toggle elements 114 a, 114 b attached to sutureterminal ends 113 a, 113 b.

[0134]FIG. 21F shows wire element toggle 114 attached by welding orother type of mounting mechanism to suture terminal end 113.

[0135]FIG. 22A shows needle delivery system 124 which retains wireelement toggle 114 and wire suture 112. Toggle element 114 includes anopen loop 135 and a linear segment 136. Linear segment 136 rests againstthe proximal end wall of a needle slot 130. Open loop toggles are shownin FIGS. 21E, 22A, C and D.

[0136]FIG. 22B shows needle 124 having a toggle needle slot 130 and wireelement toggle 114 having a depending leg 118 resting on toggle needleslot 130. Suture wire 110 is disposed in lumen 126 of needle 124. Leg118 is used to mount suture wire 110 in the delivery needle. Legs 119are shown in FIGS. 21A, 21B, 21D and 21F.

[0137]FIG. 22C shows toggle element 114 with open loop 135 disposed intoggle needle slot 130.

[0138]FIG. 22D shows wire element toggle 114 in toggle slot 130 ofneedle 124. Needle 124 also includes a suture slot 134 through whichruns wire suture 110. Wire element toggle 114 is retained within toggleslot 130 via its open loop. The operation of the wire suture and wireelement toggle is substantially similar to the suture toggle discussedabove in connection with FIGS. 1-13. The operation and deployment of thesuture toggle and the suture needle is also similar to that discussedabove in connection with FIGS. 1-13.

[0139]FIGS. 23A,23B and 23C diagrammatically show a delivery system 210used in connection with fascia 220 to deploy suture toggles in a mannerdiscussed above in connection with FIGS. 1-13 and 21-22. The deploymentdevice shown and described in connection with FIGS. 23-24 is typicallyused in laparoscopic surgery. However, it maybe used whenever a surgeonneeds to suture fascia.

[0140] Delivery system 210 includes handle 222 and central tube 224which carries thread 226 at its distal end. Thread 226 coacts withthreads on an inboard surface of collar 228. Collar 228 is attached tosuture needles 230,232. Suture needles 230,232 move within needlepassages in needle retention body 234. This mechanical theory andfeature is generally discussed above in connection with needle retentionbody 72 and FIGS. 14A and 18.

[0141] Central body or tube 224 has a mid-section 224 a and a distalsection 224 b. At the distal end of distal section 224 b, a radiallylarge fascia lift element 240 is mounted. A plunge cone 242 is mountedto the distal end of enlarged lift segment 240. Fascia is lifted by theproximal, peripheral radial lip 240 a of lift element 240.

[0142]FIG. 23B diagrammatically shows an operational state of deliverysystem 210. The distal ends 230 a, 232 a of needles 230, 232 protrudeaxially beyond the distal end of needle retainer 234.

[0143] In operation, the suture toggles are deposited in the fascia byrotational movement of body 224 to collar 228 translated into axialmovement and needle ends 230 a, 232 a are withdrawn by counter rotationof central tube 224 thereby moving collar 228 in a proximal direction.Withdraw of the suture needles causes the suture toggles to remainembedded in the fascia.

[0144]FIG. 23C shows a delivery system 210 with suture wires 110 a, 110b disposed outboard of suture needle ends 230 a,232 a. The suture wiresare run through capture channels 250,252 on either side of needleretention body 234.

[0145]FIG. 23D is a diagrammatic cross-sectional view from theperspective of section lines 23D′-23D″ in FIG. 23C. Suture capture body252 captures suture wire 110 b in a channel 254. Upon deployment of thetoggle suture in the fascia, the physician simply moves the suture wireoutboard of the channel 254 and closes the site.

[0146]FIGS. 24A, 24B and 24C diagrammatically illustrate the operationof delivery system 210. In FIG. 24A, cone 242 and fascia support or liftelement 240 have been inserted into a hole or cavity formed in fascia220. The surgeon or physician allows the fascia to rest thereby closingthe hole about distal cental rod segment 224 b.

[0147] In FIG. 24B, the physician gently raises delivery system 210 inthe direction shown by arrow 275. Lift element lip 240 a causesfascia220 to rise thereby lifting fascia220 above underlying tissueelements 220 a. Further, the physician rotates central handle 224 withrespect to collar 228 thereby causing suture needles 230 a, 232 a toprotrude beyond the distal end of needle retention body 234.

[0148] In FIG. 24C, the physician has completely rotated handle 224thereby completely deploying needle ends 230 a, 232 a through fascia220. Upon complete deployment of the toggle carrying sutures, thetoggles engage the inboard edge or side of fascia 220 preferably in theinterstitial space between underlying material 220 a. The toggles arecaught by the fascia, leave the toggle carrying needles, latch onto theinboard surface of fascia 220 and remain in the fascia. The surgeon thencounter rotates handle 224 with respect to collar 228 therebywithdrawing suture needle ends 230 a, 232 a from fascia 220.Essentially, needles 230, 232 are withdrawn and recaptured by needleretention body 234. The surgeon then gently withdraws fascia liftelement 240 from fascia220. The toggles are embedded in the inboardsurface of the fascia and the surgeon can then close the fascia.

[0149]FIGS. 25A, B, C and D diagrammatically illustrate a wire togglewith a wire suture 310 and a wire toggle element 312. Toggle element 312is configured as a hook with a crook or bend element 316 (0.008 orgreater), an angled body segment 314 and an end segment 318. End segment318 is generally in a plane parallel with respect to the axialcenterline of wire suture 310 assuming the suture is laid out straight.The length It of hook end 318 is approximately 0.04. This configurationlocks onto the inboard surface of the bodily structure after the wiresuture is deployed beneath the surface. See generally FIG. 25D.

[0150]FIG. 25B illustrates toggle wire element 312 with a stepped radiusor curve consisting of proximal angled segment 320, normal segment 322(having a running length wr of about 0.020) and angled segment 323. Hookspan g from suture 310 to end segment 318 is about 0.60. FIG. 25C showshooked toggle 312 deployed in a delivery needle 324. In the illustratedembodiment, the needle does not have a suture slot.

[0151]FIG. 25D illustrates the deployment of hook toggles 312, 312 a andthe integral or attached wire sutures 310,310 a twisted or crossed. Inthe configuration, the wire sutures are enabled to close the illustratedgap in body structure 340.

[0152]FIGS. 26A through 34 illustrate various suture toggles and some ofthe steps required to manufacture certain embodiments of the suturetoggle. In the discussion that follows, a “suture toggle” refers to thesuture thread together with a toggle attached at or near the suturethread's terminal end or terminal end region. A toggle is simply thetoggle bar or toggle head which is attached at or near the terminal endregion of the suture thread. Since some manufacturing processes utilizean end segment or end region of the thread for attachment to a toggle,the term “terminal end region” hereinafter refers to a length of suturethread at an end thereof.

[0153]FIG. 26A diagrammatically illustrates a suture toggle 10 with itstoggle 14 attached to suture thread 12 such that the two define an acuteangle a therebetween. Acute angle a ranges from between 25 degrees to 65degrees. The preferred angle of toggle 14 with respect to suture thread12 is the angle of the piercing terminal end segment 28 of suturedelivery needle 24 with respect to its axial centerline (see FIGS. 2A,2B, 4A and 4B). At the preferred angle both the toggle 14 and thepiercing terminal end segment 28 are substantially parallel (see FIG.9B). In FIG. 26A, toggle 14 has a cylindrical shape with rounded ends 22a, 22 b. In FIG. 26B, suture thread 12 is disposed offset from a centralregion 25 of toggle 14. Toggle 14 is rectangular with chamfered orbeveled edges similar to toggle 14 in FIGS. 8A. Toggle 14 may havevarying characteristics, including shapes and dimensions, such that, forexample, toggle 14 has a pick-like appearance with cross-sectional areasnear the middle of the toggle being greater than cross-sectional areasnear the ends of the toggle.

[0154]FIG. 27A diagrammatically illustrates a suture toggle 10substantially similar to the suture toggle in FIG. 26A. The suturetoggle 10 in FIG. 27A is rotated such that the toggle aligns with thelongitudinal axis of suture thread 12. Note that the width of toggle 14is slightly larger than the width of suture thread 12. FIG. 27Bdiagrammatically illustrates a cross-sectional view of suture toggle 10from the perspective of section line 27B′-27B″ in FIG. 27A. FIG. 27Balso shows toggle 14 slightly wider than suture thread 12. Although thewidth of toggle 14 can be the same as the diameter of suture thread 12,in the preferred embodiment toggle 14 is slightly wider than thediameter of suture thread 12.

[0155] Toggle 14 of suture toggle 10 illustrated in FIGS. 26A through27B may include an extending leg, a protruding leg or a protruding tab,as discussed above in connection with FIGS. 1A through 13C. In addition,suture toggle 10 in FIGS. 26A through 27B functions substantiallysimilar to suture toggle 10 discussed above in connection with FIGS. 1Athrough 13C.

[0156] FIGS. 28A through 28G2 illustrate components of suture toggle 10and some of the steps necessary for its manufacture. FIG. 28Adiagrammatically illustrates toggle 14 having an elongated cylindricalshape with ends 22 a, 22 b being substantially perpendicular tolongitudinal axis line 32. Ends 22 a, 22 b can be rounded or includeprotrusions. FIG. 28B1 diagrammatically illustrates toggle 14 defining achannel 410 with a channel face 420. Channel 410 extends fromapproximately the center of elongated toggle 14 to end 22 a whichdefines a channel mouth 416. In FIG. 28B1, channel 410 is shallow nearthe middle of toggle 14 and deeper at the channel mouth region 416.Channel 410 may include other configurations. For example, channel 210may have substantially the same dimension as channel mouth 416throughout. FIG. 28B2 diagrammatically illustrates a cross-sectionalview of toggle 14 from the perspective of 28B2′-28B2″ in FIG. 28B1. FIG.28C diagrammatically illustrates toggle 14 including channel 410 withchannel face 420. Channel face 420 includes score marks, grooves orridges 418 making the surface of channel face 420 rough. FIG. 28Ddepicts suture thread 12 with end segment 17 and terminal end face 23.Suture thread 12 is dangling over vat 434 containing a liquid polymer orother biocompatible coating material 430.

[0157]FIG. 28E diagrammatically illustrates toggle 14 with a portion ofthe end segment 17 of a suture thread 12 positioned within channel 410of the toggle. End segment 17 of suture thread 12 is stiff. FIG. 28F1diagrammatically illustrates toggle 14 with a portion of the end segmentof suture thread 12 swaged within channel 410 of toggle 14, thus forminga closed channel thereat. Channel walls 414 a, 414 b are illustratedpartially encircling the aforementioned portion of suture thread 12.FIG. 28F2 diagrammatically illustrates a partial, side or end view oftoggle 14 and suture thread 12. Terminal end face 23 of suture thread 12and a portion of its end segment are caught within closed channel 410 oftoggle 14. Channel walls 414 a, 414 b encircle suture thread 12 suchthat the suture thread is trapped within toggle 14. Channel walls 414 a,414 b can be formed long enough to come in contact with each other oroverlap at region 412. Note that in FIG. 28F2 suture thread 12 has adiameter slightly smaller than the diameter of toggle 14.

[0158]FIG. 28G1 illustrates toggle 14 and end segment 17 of suturetoggle 10 being sprayed by a polymer, poly-acetate, biocompatibleacrylic (cyno-acrylic) or other biocompatible material 440.

[0159]FIG. 28G2 illustrates suture toggle 10 prior to being immersed ina vat 434 filled with a polymer, a poly-acetate or a biocompatiblematerial 440. The suture thread end is stiffened in a cold dip, lowerthan the suture thread melt point or flow point.

[0160]FIG. 29A diagrammatically illustrates a hollow, elongated toggle14 defining a longitudinal passage 436 and a hole 444. Toggle 14 may bemade of a metallic material such as an nitinol or stainless steel, ormay be made of any biocompatible material. The illustration of suturethread 12 and vat 434 in FIG. 29B1 is substantially similar to theillustration in FIG. 28D. FIG. 29B2 illustrates one method of stiffeningend segment 17 of suture thread 12. End segment 17 of suture toggle 10is lying on surface 442 and being sprayed by a polymer, poly-acetate orbiocompatible material 440.

[0161]FIG. 29C diagrammatically illustrates terminal end region 19 ofsuture thread 12 near end 22 b of toggle 14. Wedge mandrel 446 is shownwith wedged end 448 adjacent end 22 a of toggle 14. FIG. 29D1diagrammatically illustrates toggle 14 with a portion of suture thread12 inserted in passage 436 at end 22 b and wedge mandrel 446 inserted atthe other end of passage 436 at end 22 a. FIG. 29D2 diagrammaticallyillustrates a partial cross-sectional view of toggle 14, suture thread12 and wedge mandrel 446 illustrated in FIG. 29D1. The terminal end face23 of suture thread 12 abuts the tip of mandrel 446.

[0162]FIG. 30A diagrammatically illustrates a suture thread 12 withstiffened end segment 17 positioned to be inserted into hole 444 ontoggle 14. FIGS. 30B and 30C illustrate toggle 14 with a portion ofstiffened end segment 17 of suture thread 12 inserted into hole 444 andlying within a cavity or a passage 438 of toggle 14. The portion ofstiffened end segment 17 of suture thread 12 lying outside of toggle 14and the longitudinal axis of toggle 14 define an acute angle a. FIGS.31A and 31B diagrammatically illustrate alternative embodiments oftoggle 14. Toggle 14 in FIG. 31A includes a passage 438 running from end22 b to hole 444. Toggle 14 in FIG. 31B includes a longitudinal passage436 running the length of toggle 14 with hole 444 communicating withlongitudinal passage 436.

[0163]FIG. 32 diagrammatically illustrates a mold die 450 a, 450 bdefining a toggle-shaped cavity 452 and a suture thread-shaped cavity454 communicating therewith. Mold die 450 a, 450 b is illustrated as twoplates. However, the mold die can consist of any number of plates,including a single piece. In addition, mold 450 may also include aprotruding member-shaped cavity communicating with the toggle cavity452. In FIG. 32, mold plate 450 b includes an injection mold port 456communicating with toggle cavity 452.

[0164]FIG. 33 diagrammatically illustrates suture toggle 10 withrectangular-shaped toggle 14. Suture thread 12 is disposed offset fromcentral region 25 of toggle 14. FIG. 34 diagrammatically illustratessuture toggle 10 loaded within the lumen 26 of delivery needle 24. Theelongated toggle 14 is substantially parallel to piercing end 28 ofneedle 24.

[0165] One embodiment of the suture toggle 10 is manufactured by thefollowing method in which toggle 14 is swaged onto the suture thread 12or suture thread 12 is swaged within toggle 14. The swaged toggle iscrushed or closed about 0.002 inches from original size. The first stepincludes preparing a toggle 14 to receive a suture thread 12. As shownin FIG. 28B1, a channel or cutout must be created on toggle 14. Channelor cutout 410 can be created by boring away a portion of toggle 14,cutting toggle 14 either by mechanical means or a laser, by grindingtoggle 14, by molding toggle 14, or by forming toggle 14. At least aportion of the toggle must define a channel or cutout within which asuture thread will fit. The channel can be a groove, slit or similaropening sufficient to accommodate a portion of the end segment 17 of thesuture thread. Determination of the location of channel 410 depends uponthe ultimate location of suture thread 12 relative to toggle 14. Ifsuture thread 12 is to be substantially, centrally attached to toggle 14(e.g., see FIGS. 1A, 5A and 26A), then channel 410 must include an openside region capable of accommodating an end segment of the suture threadlocated at or near the center of toggle 14. In the same vein, if suturethread 12 is to be disposed offset from central region 25 of toggle 14(e.g., see FIGS. 2B, 5C, 26B and 33), then the open side region shouldbe located at or near the desired location on the toggle to form theconnection between the toggle and thread.

[0166] The channel or cutout 410 defined by toggle 14 may then beroughened as shown in FIG. 28C. The roughening may be accomplishedduring the process utilized to create the channel or thereafter. Forexample, if the channel is formed using a drill, the drill bit utilizedmay leave channel face 420 rough. The channel surface 420 may also bescored or roughened through use of an abrasive, a tumble-stone process,or by cutting ridges 418 into the toggle material. Although theroughening step is not required, it is preferred. The roughening ofchannel surface 420 enhances the friction or grip between the togglesurface and suture thread once the suture thread 12 is attached to thetoggle 14.

[0167] Prior to positioning the suture thread 12 in channel 410, an endsegment of suture thread 12 should be stiffened. Stiffening of endsegment 17 can be accomplished by cold dipping or immersing end segment17 in a polymer or biocompatible material (see FIG. 28D). Thetemperature of the cold dip material 430 should be lower than themelting point or flow point of the suture thread.

[0168] Alternatively, end segment 17 can be stiffened by spraying thesegment with a biocompatible acrylic or other biocompatible stiffeningagent (see FIG. 29B2). The suture thread 12 is placed on a flat surface442 (FIG. 29B2) and sprayed with a biocompatible stiffening material440. The suture thread 12 is rolled as indicated by arrow 460 in orderto coat the surface of end segment 17 of suture thread 12. The suturethread is then allowed to dry enabling the coating material to cure, dryor cool.

[0169] A portion of the stiffened end segment 17 of suture thread 12 isplaced in channel 410 (see FIG. 28E). The suture thread end segment 17should be positioned such that the portion of the stiffened end segmentoutside the channel 410 forms the desired acute angle a relative to thelongitudinal axis of toggle 14. Of course, the suture may also be placedsuch that the suture thread 12 and toggle 14 form a right angle or areperpendicular with respect to each other.

[0170] After placing the portion of stiffened suture thread end segment17 within channel 410, the toggle channel 410 is swaged closed aboutthat portion. In FIG. 28E, swaging is accomplished by application of aforce to toggle 14 in the direction of arrows F. In FIG. 28F 1, channelwalls 414 a, 414 b of toggle 14 have been swaged about a portion ofstiffened end 17. Toggle 14 or channel 410 can be formed such that theswaging produces overlapping channel walls 414 a, 414 b. After swaging,toggle 14 may become deformed to create a new shape. Toggle 14 andchannel 410 defined thereby may be designed to form a predeterminedshape upon completion of the swaging step.

[0171] After swaging, the toggle 14 and suture thread end segment 17 maybe coated with a polymer or biocompatible material 440 in either of thetwo manners described above in connection with stiffening of the suturethread. Prior to the coating process, or prior to the swaging process,the toggle may be roughened in order to enhance the bonding of thecoating to the toggle surface. Such roughening may be accomplished withan abrasive, as described earlier in connection with roughening of thechannel surface, or with plasma. The suture toggle 10 is exposed to hotgas which cleans the surfaces of the suture thread and toggle ofimpurities and roughens the surfaces.

[0172] Another embodiment of the suture toggle 10 is manufactured by thefollowing process. An elongated toggle 14 is bored along itslongitudinal axis, thereby creating a longitudinal passage through thetoggle. The passage can traverse the entire toggle (see FIG. 29A and31B) or a portion necessary for attachment of a suture thread (see FIG.31A). A hole 444 is then bored into the side of the elongated toggle.The location of hole 444 will determine the attachment location ofsuture thread 12 relative to toggle 14. Again, passage 436 and hole 444can be created using numerous processes or a combination of them,including those discussed in connection with creation of the channel orcutout on toggle 14.

[0173] In one embodiment, an end segment 17 of suture thread 12 isstiffened in the same manner as discussed above in connection withthread 12 of the swaged suture toggle 10. If the passage 436 traversesthe entire toggle, then the non-stiffened end is inserted into one endof toggle 14 and wedge mandrel 446 into the other end as illustrated inFIGS. 29C, 29D1 and 29D2. Mandrel 446 forces end region 19 of suturethread 12 through hole 444 on toggle 14. The length of suture thread 12is then run through the passage until a portion of the stiffened endsegment 17 is within passage 436 and a portion protrudes from hole 444.The toggle passage 436 is swaged about the portion of end segment 17lying therein (see FIG. 30C). If the passage 436 traverses only aportion of toggle 14 as shown in FIG. 30B, for example, then thestiffened suture thread end segment 17 is inserted through hole 444 andinto passage 436. Subsequently, the same swaging force is applied tocapture a portion of the suture thread 12 within toggle 14. Again, inthis alternative embodiment, it is preferred that the toggle be coatedwith a biocompatible coating as described earlier in connection with theswaged suture toggle including a channel.

[0174] Another embodiment of the suture toggle 10 is manufactured by thefollowing molding process. A mold die is created having the desireddimensions and characteristics of the particular toggle shape to bemanufactured. For example, a toggle 14 having protruding tabs or anextending leg would require a toggle cavity 452 with a cavity for theprotruding member or extending leg communicating therewith. In FIG. 32,mold die 450 a, 450 b defines a toggle-shaped cavity 452 and a suturethread-shaped cavity 454 communicating therewith, but does not include aprotruding member cavity. Next, a suture thread 12 is inserted in themold die such that when the toggle is formed it will be disposed on thesuture thread. In the preferred embodiment, an end segment 17 of suturethread 12 is stiffened. The stiffening of end segment 17 may beaccomplished prior to molding toggle 14 by one of the steps discussedearlier in connection with manufacturing of the swaged suture toggles,or may be accomplished during the molding process. Upon inserting aportion of suture thread 12 into the suture thread cavity 454, toggle 14is molded by conventional means as known in the art. For example, aliquified polymer is injected into injection mold port 456. After themolding process is complete, suture toggle 10 is removed from die 450 a,450 b. In the preferred embodiment, either the material used to formtoggle 14 or the molding process, or a combination thereof, will resultin toggle 14 being stiffer or having a higher durometer measurement thansuture thread 12.

[0175] The claims appended hereto are meant to cover modifications andchanges within the scope and spirit of the present invention.

What is claimed is:
 1. A self-securing suture toggle comprising a suturethread having a stiff end segment at a terminal end and a toggledisposed on said terminal end, said toggle and said stiff end segmentdefining an acute angle between 25 degrees and 55 degrees.
 2. A sutureas claimed in claim 1 wherein said stiff end segment is made by one of acoating process and a hardening process.
 3. A suture as claimed in claim1 wherein said stiff end segment is coated with one of a polymer, abiocompatible acrylic and a biocompatible material.
 4. A suture asclaimed in claim 1 wherein said toggle is one of a metal body toggle anda biocompatible plastic body toggle.
 5. A suture as claimed in claim 1wherein said toggle and said stiff end segment are substantially coveredby a coating of biocompatible material.
 6. A suture as claimed in claim1 wherein said suture thread is disposed offset from a central region ofsaid toggle.
 7. A suture as claimed in claim 1 wherein said toggle hasone of a cylindrical shape, a rectangular shape and a rectangular shapewith beveled edges.
 8. A self-securing suture toggle comprising a suturethread having a stiff end segment at a terminal end and a toggledisposed on said terminal end, said toggle and said stiff end segmentdefining an acute angle and a biocompatible material substantiallycoating said toggle and said stiff end segment.
 9. A suture as claimedin claim 8 wherein said acute angle is one of an angle from 25 degreesto 65 degrees.
 10. A self-securing suture toggle comprising a suturethread having a stiff end segment at a terminal end and a toggledisposed on said terminal end, and a portion of said stiff end segmentswaged onto said toggle in a closed channel.
 11. A suture as claimed inclaim 10 wherein said suture thread is disposed offset from a centralregion of said toggle.
 12. A suture as claimed in claim 10 wherein saidtoggle is an elongated toggle having two opposing ends and said suturethread is disposed near one of said opposing ends.
 13. A suture asclaimed in claim 10 wherein said toggle and said stiff end segmentdefine an acute angle.
 14. A suture as claimed in claim 13 wherein saidacute angle is one of an angle from 25 degrees to 65 degrees.
 15. Asuture as claimed in claim 10 wherein said stiff end segment is made byone of a coating process and a hardening process.
 16. A suture asclaimed in claim 10 wherein said stiff end segment is coated with one ofa polymer, a biocompatible acrylic and a biocompatible material.
 17. Asuture as claimed in claim 10 wherein said toggle is one of a metal bodytoggle and a biocompatible plastic body toggle.
 18. A suture as claimedin claim 10 wherein said toggle and said stiff end segment aresubstantially covered by a coating of biocompatible material.
 19. Asuture as claimed in claim 10 wherein said toggle has one of acylindrical shape, a rectangular shape and a rectangular shape withbeveled edges.
 20. A self-securing suture toggle comprising a suturethread having a stiff end segment at a terminal end and a toggledisposed on said terminal end, and a portion of said stiff end segmentswaged onto said toggle in a closed cutout.
 21. A suture as claimed inclaim 20 wherein said suture thread is disposed offset from a centralregion of said toggle.
 22. A suture as claimed in claim 20 wherein saidtoggle is an elongated toggle having two opposing ends and said suturethread is disposed near one of said opposing ends.
 23. A suture asclaimed in claim 20 wherein said toggle and said stiff end segmentdefine an acute angle.
 24. A suture as claimed in claim 23 wherein saidacute angle is one of an angle from 25 degrees to 65 degrees.
 25. Asuture as claimed in claim 24 wherein said stiff end segment is made byone of a coating process and a hardening process.
 26. A suture asclaimed in claim 20 wherein said stiff end segment is coated with one ofa polymer, a biocompatible acrylic and a biocompatible material.
 27. Asuture as claimed in claim 20 wherein said toggle is one of a metal bodytoggle and a biocompatible plastic body toggle.
 28. A suture as claimedin claim 20 wherein said toggle and said stiff end segment aresubstantially covered by a coating of biocompatible material.
 29. Asuture as claimed in claim 20 wherein said toggle has one of acylindrical shape, a rectangular shape and a rectangular shape withbeveled edges.
 30. A method of manufacture for producing a suture togglefrom a suture thread having an end segment at a terminal end thereof,and a toggle comprising the steps of: creating at least a partialchannel on said toggle; stiffening the suture thread end segment;positioning a portion of the stiffened end segment in said channel; andswaging said toggle channel closed about said portion of said stiffenedend segment.
 31. A method as claimed in claim 30 wherein said creatingstep includes one of a boring step, a forming step, a cutting step, agrinding step and a molding step to create said partial channel on saidtoggle.
 32. A method as claimed in claim 30 including the step ofcreating said channel with an open side region sized to accommodate saidstiffened end segment.
 33. A method as claimed in claim 30 furthercomprising the step of roughening said suture channel in said toggleafter said creating step.
 34. A method as claimed in claim 30 whereinsaid positioning step includes aligning said stiffened end segment andsaid toggle to define an acute angle therebetween.
 35. A method asclaimed in claim 30 wherein said stiffening step includes one of colddipping said suture thread end segment into a polymer and spraying saidsuture thread end segment with a biocompatible acrylic.
 36. A method asclaimed in claim 35 further comprising the step of drying said stiffenedend segment prior to said positioning step.
 37. A method as claimed inclaim 30 further comprising the step of coating said toggle and saidsuture thread end segment with a biocompatible polymer after saidswaging step.
 38. A method of manufacture for producing a suture togglefrom a suture thread having an end segment at a terminal end thereof andan elongated toggle having a longitudinal axis comprising the steps of:creating a longitudinal passage through said toggle; forming a lateralhole through said toggle and into said passage; stiffening the suturethread end segment; placing said suture thread in said passage andthrough said hole such that a portion of the stiffened end segment liesin said passage and protrudes from said hole; swaging the toggle closedabout the captured stiffened end segment; and coating said toggle andsaid portion of said stiffened end segment with a biocompatiblematerial.
 39. A method as claimed in claim 38 wherein said creating stepand said forming step include cutting said toggle with a laser.
 40. Amethod as claimed in claim 38 further comprising the step of rougheningsaid toggle after one of said creating step and said forming step.
 41. Amethod as claimed in claim 38 wherein said placing step includesaligning said stiffened end segment and said toggle to define an acuteangle therebetween.
 42. A method as claimed in claim 38 wherein saidstiffening step includes one of cold dipping said suture thread endsegment into a polymer and spraying said suture thread end segment witha biocompatible acrylic.
 43. A method as claimed in claim 42 furthercomprising the step of drying said stiffened end segment prior to saidplacing step.
 44. A method of manufacture for producing a suture togglewith a suture thread having an end segment at a terminal end thereofcomprising the steps of: providing a mold defining a toggle-shapedcavity and a suture thread-shaped cavity communicating therewith;stiffening the suture thread end segment; positioning said suture threadend segment within said suture thread cavity; molding a toggle onto thepositioned suture thread end segment at an acute angle with said mold.45. A method as claimed in claim 44 wherein said acute angle is between25 degrees and 65 degrees.
 46. A method as claimed in claim 44 whereinsaid stiffening step includes one of cold dipping said suture thread endsegment into a polymer and spraying said suture thread end segment witha biocompatible acrylic.
 47. A method as claimed in claim 46 furthercomprising the step of drying said stiffened end segment prior to saidattaching step.
 48. A method as claimed in claim 44 wherein said mold insaid providing step defines a toggle cavity having one of a cylindricalshape, a rectangular shape and a rectangular shape with beveled edges.49. A method as claimed in claim 44 wherein said positioning step occursprior to said stiffening step and said stiffening step occurssubstantially concurrently with said molding step.
 50. A method asclaimed in claim 44 wherein said toggle cavity includes a cavitydefining a protruding member communicating therewith.
 51. A method ofmanufacture for producing a suture toggle with a suture thread having anend segment at a terminal end thereof comprising the steps of: providinga mold defining a toggle-shaped cavity, a suture thread-shaped cavityand a protruding member-shaped cavity, the suture thread and protrudingmember cavities communicating with the toggle cavity; stiffening thesuture thread end segment; positioning said suture thread end segmentwithin said suture thread cavity; and molding a toggle with a protrudingmember onto the positioned suture thread end segment with said mold. 52.A method as claimed in claim 51 wherein said molding step includesmolding said toggle with said protruding member onto said positionedsuture thread end segment at an acute angle.
 53. A method as claimed inclaim 52 wherein said acute angle is between 25 degrees and 65 degrees.54. A method as claimed in claim 51 wherein said stiffening stepincludes one of cold dipping said suture thread end segment into apolymer and spraying said suture thread end segment with a biocompatibleacrylic.
 55. A method as claimed in claim 51 further comprising the stepof drying said stiffened end segment prior to said attaching step.
 56. Amethod as claimed in claim 51 wherein said mold in said providing stepdefines a toggle cavity having one of a cylindrical shape, rectangularshape and a rectangular shape with beveled edges.
 57. A method asclaimed in claim 51 wherein said positioning step occurs prior to saidstiffening step and said stiffening step occurs substantiallyconcurrently with said molding step.